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Quality Maturity Assistance

In every pharmaceutical organization, role of IT is becoming increasingly more involved and crucial for achieving compliance objectives as most of critical processes are now software driven. IT departments are not only involved in regular support services, they are now becoming focal point of many audits. In such a scenario, it's essential that IT department is equally strong in Quality Management as desired in such GxP regulated environment. Having a defined and documented QMS is equally as important as nicely developed software or robust infrastructure.

We have introduced this unique concept of Quality Maturity Assistance (QMA) for our clients in pharmaceutical industry specifically for providing ITQA services. We can help you to reach next stage of your quality ladder by way of auditing, training and documentation support.

Be it your Computer System Compliance documents or your ISO/QMS documents for IT, we can help you in making sure your practices and documentation are current and as per best practices. We help your IT departments to create their QMS and establish processes so that IT becomes an integral part of company's QA objectives.

We also work with equipment and software vendors providing solutions and products to the regulated industries. We provide wide range of services to meet the specific needs of the vendors catering to the GxP companies.

We can assist in strengthening following documentation:

  • Quality Plans

  • Validation Packages

  • SOPs

  • IT Policies

  • Information Security Policies

  • Risk Assessments

  • Templates

  • Checklists and Forms

Computerised System (IT) SOPs

Often organisations do extensive computerised system validation programs and carryout detailed documentation and execution to make sure that their computerised systems are compliant and validated for regulated environment. However after implanting the same, they overlook the need for IT SOPs. This lapse leads to delays and later on results into losing validated state for these computer systems during operations.

Identifying which SOPs are required at the beginning of the project and listing them in the validation plan gives you the opportunity to finish them by the time you finish your first validation project and also help you during lifecycle management. Recovery from a failure to maintain control of a regulated system during the operation phase can be both time-consuming and expensive, and increase the risk to data integrity, product quality and patient safety.

Based on our years of practical experience in the computerised system compliance field and closely following various GAMP guidelines and Good Practices Guides (GPGs), we have in-depth knowledge of life cycle management requirements of Computerised Systems. We can provide you full set of absolutely essential IT SOPs that you will nee to have in place as recommended by GAMP good practices. If you do not have following IT SOPs in place, you will surely face problems during audit and definitely during operational lifecycle.

  • Computerised System Validation

  • Vendor Qualification

  • Impact Assessment

  • Risk Assessment

  • User Management

  • System Maintenance

  • Incident Management

  • Operational Change Management

  • Periodic Review

  • Data Backup, Archiving and Restore

  • Disaster Recovery

  • Security Management

  • Periodic Review

We can help you with templates, readymade SOPs or customisation of SOPs to fit into your existing Quality Management System seamlessly. Step by step pre-written standard operating procedures, forms, templates and manuals in the area of GAMP (Good Automated Manufacturing Practice) are created for small and medium size pharmaceutical manufacturing environments. Content of our procedures are not only guidelines but detail know how instructions which will help you to build up your documentation and practices from scratch.

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